efficacy and safety of viaskin peanut in children with immunoglobulin e (ige)-mediated peanut allergy

Conditions: Peanut Allergy

Summary: the pepites study evaluates the efficacy and safety of viaskin peanut 250 µg peanut protein to induce desensitization to peanut in peanut-allergic children 4 through 11 years of age after a 12-month treatment by epicutaneous immunotherapy (epit).

this is a 12-month, phase iii, double-blind, placebo-controlled, randomized study to assess the efficacy and safety of viaskin peanut, dosed at 250µg peanut protein (per patch) in peanut-allergic children from 4 through 11 years of age. the overall maximum study duration for each subject is approximately 61 weeks (6-week screening period, 12-month treatment period and 2-week follow-up period). during the screening period, subjects will undergo a first screening visit and an entry double-blind, placebo-controlled food challenge (dbpcfc) to peanut to confirm their allergy and their entry peanut eliciting dose (ed). the starting dose of the challenge will be 1 mg peanut protein and will escalate up to a highest dose of 300mg peanut protein. subjects who react at or below the dose of 300mg peanut protein are considered eligible. randomization of eligible subjects will occur in a 2:1 ratio to viaskin peanut dosed at 250µg peanut protein (active treatment) or placebo. subjects will be stratified at randomization by their entry/screening dbpcfc ed in 1 of the following 2 strata and by study center: * stratum 1: children with a screening ed of 1mg, 3mg or 10mg; * stratum 2: children with a screening ed of 30mg, 100mg or 300mg. subjects will apply a viaskin patch containing either peanut protein or placebo daily for a period of 12 months. at month 12, a post-treatment dbpcfc to peanut will be performed, with a starting dose of 1 mg peanut protein with escalation up to a highest dose of 2,000 mg peanut protein. this evaluation will help determine the primary efficacy endpoint of this pivotal study.

Eligibility criteria:
main inclusion criteria: 1. male or female children aged 4 through 11 years; 2. physician-diagnosis of peanut allergy or children with a well documented medical history of ige-mediated symptoms after ingestion of peanut and currently following a strict peanut-free diet, but without a physician diagnosis; 3. peanut-specific ige level (immunocap system) \>0.7 ku/l; 4. positive peanut skin prick test (spt) with a largest wheal diameter: * ≥6 mm for children 4 through 5 years of age at visit 1, * ≥8 mm for children 6 years and above at visit 1; 5. positive dbpcfc at ≤300 mg peanut protein. main exclusion criteria: 1. history of severe anaphylaxis to peanut with any of the following symptoms: hypotension, hypoxia, neurological compromise (collapse, loss of consciousness or incontinence); 2. generalized dermatologic disease 3. diagnosis of mast cell disorders, including mastocytosis or uricaria pigmentosa as well as hereditary or idiopathic angioedema; 4. diagnosis of asthma that fulfills any of the following criteria: * uncontrolled persistent asthma as defined by national asthma education and prevention program asthma guidelines 2007 or by global initiative for asthma guidelines 2015, * asthma treated with either a high daily high dose of inhaled corticosteroid or with a combination therapy of a medium or high daily dose of inhaled corticosteroid with a long acting inhaled β2 agonist or with a combination therapy of a high daily dose of inhaled corticosteroid with a long acting inhaled β2 agonist. asthmatic subjects treated with a medium daily dose of inhaled corticosteroids are eligible. intermittent asthmatic subjects who require intermittent use of inhaled corticosteroids for rescue are also eligible, * two or more systemic corticosteroid courses for asthma in the past year or 1 oral corticosteroid course for asthma within 3 months prior to visit 1, or during screening period, * prior intubation/mechanical ventilation for asthma within 1 year prior to visit 1, or during screening; 5. receiving β-blocking agents, angiotensin-converting enzyme inhibitors, angiotensin-receptor blockers, calcium channel blockers or tricyclic antidepressant therapy; 6. received anti-tumor necrosis factor drugs or anti-ige drugs (such as omalizumab) or any biologic immunomodulatory therapy within 1 year prior to visit 1, during screening period or during study participation; 7. use of systemic long-acting corticosteroids within 12 weeks prior to visit 1 and/or use of systemic short-acting corticosteroids within 4 weeks prior to visit 1 or during screening; 8. prior or concomitant history of any immunotherapy to any food; 9. receiving or planning to receive any aeroallergen immunotherapy during their participation in the study. aeroallergen immunotherapy must be discontinued at the time of visit 1; 10. any disorder in which epinephrine is contraindicated such as coronary artery disease, uncontrolled hypertension, or serious ventricular arrhythmias.